Evaluation of Adipose Derived Stem Cells Exo.in Treatment of Periodontitis

Early Phase 1

• Conditions: Periodontitis
• Interventions: Biological: adipose derived stem cells exosomes

• Registration Number: NCT04270006
• Lead Sponsor: Beni-Suef University

Brief Summary

The adipose stem cells exosomes will be extracted from adipose stem cells isolated autogenously from the patient to be injected locally into the periodontal pockets in order to evaluate their regenerative effect.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-08
• Study Start: 2020-02-12
• Study First Submitted QC: 2020-02-12
• Last Update Submitted: 2020-02-12
• Study First Posted: 2020-02-17
• Last Update Posted: 2020-02-17
• Primary Completion: 2020-09-12
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Advanced periodontitis (Stage III or IV)
• Healthy patients.

Exclusion Criteria

• Smokers, Diabetic, Pregnant ladies, Under corticosteroids or contraceptive treatment,poor oral hygiene.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exosomes	adipose derived stem cells exosomes	-

Primary Outcome Measures

Name	Time	Method
change in Bone level	0 and 6 months	Cone beam C.T (CBCT)
change in pocket depth	0, 3 and 6 months	Probing depth (PD)
change in attachment level	0, 3 and 6 months	Clinical attachment level (CAL)
change in gingival inflammation	0, 3 and 6 months	Gingival index (GI)

Trial Locations

Locations (2)

Beni-Suef University; 🇪🇬 Banī Suwayf, Egypt

Cairo University; 🇪🇬 Cairo, Egypt